1. Field of the Invention
The present invention relates to a swab device, a method, and a kit for collecting and performing an immunoassay on a sample for an antigen.
2. Description of the Prior Art
A common method for testing a suspected site of infection for a particular antigen is to swab the area to collect a sample. Once collected, the sample is transferred from the swab to a testing medium wherein an immunoassay is performed to determine the presence of the antigen.
An immunoassay is an indirect measurement of the interaction between an antigen and an antibody to determine the presence or quantity of either material. If a physician suspects that a patient has a strep throat, the physician will swab the patient's throat for streptococcal infections. After the sample is collected, it is transferred from the swab to a test medium by extraction with an extraction reagent. The sample is then assayed for the presence of Strep Group A antigen by a variety of immunochemical methods.
A collected sample must therefore be transferred from the swab to a test medium in order to carry out the assay. To obtain an accurate analysis, the person performing the assay must be cautious not to contaminate the sample while transferring it. Furthermore, extra care must be taken to ensure that the antigen of interest is completely extracted from the swab. Thus, a person must be trained to properly handle a collected sample.
There is a need for a testing device which will eliminate the step of transferring the sample to a test medium after it has been collected. Such a device would allow a sample to be analyzed directly upon it. By integrating the collection and analysis steps, the risk of sample contamination would be greatly reduced while the risk of incomplete transfer would be eliminated. Furthermore, by not requiring a sample to be transferred, untrained personnel would be able to conduct a test more efficiently.
It is therefore an object of the present invention to provide an integrated device for collecting and analyzing a sample for an antigen. It is further an object of the present invention to provide a method for performing an immunoassay for a suspected antigen whereby a sample is collected on a swab and therein an analysis is performed to determine the presence of a suspected antigen. Finally, it is an overall object of the present invention to allow personnel possessing minimal amounts of scientific and laboratory background, training, skill, and experience to perform immunoassays on samples collected by a swab.